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news.Critical Therapeutics has submitted a new drug application to the FDA for a controlled-release formulation of the oral anti-inflammatory drug zileuton for asthma in adults and children aged 12 years or older.
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The new formulation only needs to be taken twice a day, whereas Zyflo, the currently marketed version of zileuton, has the drawback of requiring dosing four times a day.
Critical Therapeutics (CTI), which acquired the rights to zileuton from Abbott in 2003, collaborated with SkyePharma to develop the controlled-release formulation of the drug.
SkyePharma will receive a single-digit royalty on CTI’s sales of the controlled-release formulation of zileuton and will also manufacture the product for CTI at its plant in Lyon, France.
“Our partner expects this product to reach the market in the second half of next year when it will become another source of royalty and manufacturing income for SkyePharma,” said Frank Condella, chief executive of SkyePharma.